IFU for Sterling Silver Surgical devices

Thread Attachment browser
P

phoenix2368

Starting to get Involved
#1
#1
I work in Surgical Instruments Company, Some of our Instruments are of Sterling Silver. Sterling silver is used to make them ductile and malleable, just like Sims Sounds or Bowman Lacrimal Probes. The problem is that they get tarnished after a while. I checked all other major companies IFU's for sterling silver , but every ones IFU's say follow the manufacturers instructions. I contacted our German manufacturers regarding the shelf life of surface finish of Sterling Silver but they said that no such study been performed in Germany and when they see that thier items are getting tarnished in the shelves they just re polish them. And as such they dont have any IFU specifically for sterling silver items.
I googled any IFU for sterling silver devices used in Medical/Surgical industry but with no avail.
Can someone help me regarding some research or an IFU on Sterling Silver instruments.:cool::cool:

[FONT=&quot]I asked 2 of our vendors regarding shelf life of sterling silver surface finish , I found Some kind of Surface Finish shelf life sheet (Attached herewith) which said that it is about 6 months and after 6 months it will start getting tarnished. But another of my question is, suppose the shelf life of the finish is 6 months and we have that item in our stock for 5½ months and than we supply to our customer and within 2 weeks the item start getting tarnished so what warranty we can promise to our customer.[/FONT]
[FONT=&quot]Confusing….. Right[/FONT]
 

Attachments

Last edited:
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
Hello and welcome to the Cove :bigwave:

IMO anything medical with a shelf life of 6 months is very problematic to manage. The options I see for you:

1. Someone needs to objectively establish that the tarnishing doesn't affect safety and efficacy, and is only a cosmetic effect. This should then be communicated to customers and users, e.g. in the IFU.

2. Failing option 1, someone needs to establish a method for monitoring the finish and repolishing as required, without damaging the device's safety and efficacy. This MUST then be communicated to customers and users in the IFU.

3. Failing options 1&2, you need to establish a very efficient stock management system and clearly inform your customers upfront of the issue and the shelf life you can guarantee.

Cheers,
Ronen.
 
P

phoenix2368

Starting to get Involved
#4
#4
Since none of the Major Medical Device companies have any specific IFU on sterling Silver Instruments and were issuing a general IFU for them and it was a recurring problem for hospitals, retailers and manufacturers that how to handle the Tarnishing problem.

I made an IFU , and posting it if any one else is facing same questions and same issues.

You are most welcome to point out any deficiencies in this document.

Correction and prevention is our job.
 

Attachments

You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
U Intended Users in IFU (Instructions for Use) EU Medical Device Regulations 5
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
K No IFU, where the requirements would go? EU Medical Device Regulations 5
P IFU Translation Requirements for EU EU Medical Device Regulations 2
V Preparing the IFU in compliance with MDR 745, Chapter III EU Medical Device Regulations 2
E Commission Regulation (EU) No. 207/2012 E-IFU Applicability EU Medical Device Regulations 3
K REF symbol with product code in the IFU EU Medical Device Regulations 1
F Control of medical device IFU content Other Medical Device and Orthopedic Related Topics 3
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
K REF code and Consult IFU in Shipping carton boxes. EU Medical Device Regulations 1
S Providing IFU (Instructions for Use) in multiple languages EU Medical Device Regulations 0
S IFU on web page - Consequences if the most recent one is not uploaded EU Medical Device Regulations 3
I 2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website EU Medical Device Regulations 11
H IFU in different language other than English EU Medical Device Regulations 5
QIE Electronic IFU - new project, need input Other Medical Device and Orthopedic Related Topics 0
Z IFU (Instructions for Use) Symbol - 7010:M002 - can it be in black? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Include IFU in Class II Medical Device Marketing Brochure? US Food and Drug Administration (FDA) 2
M EU Regulations or Standards for instruction for use (IFU ) EU Medical Device Regulations 3
P IVDD - IFU related requirements - Type of information/statement expected EU Medical Device Regulations 1
K Label - IFU requirement, maybe? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Electrosurgical devices/surgery IFU contraindications EU Medical Device Regulations 2
N Updating class I device IFU with instructions to use class II cleared device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Product Instruction for Use Manual (IFU) - Obligation to list the standard used 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Ajit Basrur Incoming Inspection for Instructions for Use (IFU) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Product Instructions (IFU) - Placement Requirements - ISO 13485:2003/2016 Other ISO and International Standards and European Regulations 2
D 207/2012 Update for MDR (?) - Instructions for Use (IFU) EU Medical Device Regulations 7
B IFU and deviation 7 in ISO 14971 Annex ZA ISO 14971 - Medical Device Risk Management 1
F EMC (Electromagnetic Compatibility) Conformity Charts - IFU Requirements Misc. Quality Assurance and Business Systems Related Topics 3
O Regulatory Notification for IVD IFU Instructions Revision ISO 13485:2016 - Medical Device Quality Management Systems 3
E Does posting your IFU on your website constitute elabelling? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
N Is Notified Body approval necessary for small changes to IVD IFU? CE Marking (Conformité Européene) / CB Scheme 7
M Laminating abbreviated Operators Manual to IFU's and DFU's ISO 13485:2016 - Medical Device Quality Management Systems 1
B Brazil ANVISA Medical Device Labeling/IFU Requirements Other Medical Device Regulations World-Wide 1
E IFU Changes - How it is ensured that IFU changes reach Surgeons EU Medical Device Regulations 4
J Canada Bulk Packaging and IFU requirements for Class IIa and IIb Medical Devices Canada Medical Device Regulations 2
J Medical Device Procedure Pack IFU's (Instructions for Use) ISO 13485:2016 - Medical Device Quality Management Systems 5
R How and Where can I find IFU (Instructions For Use) examples? ISO 13485:2016 - Medical Device Quality Management Systems 6
M Orthopedic IFU ( Instruction For Use ) EU Medical Device Regulations 3
J Domestic and International Medical Device IFU (Instructions for Use) Other US Medical Device Regulations 3
G Medical Device IFU (Instructions for Use) Translation Requirements EU Medical Device Regulations 4
E Changes to IFU (Instructions for Use) on a CE Marked Medical Device ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
sagai Electronic Instructions for Use (IFU) of Medical Devices EU Medical Device Regulations 10
R Class II Medical Device - Marketing vs. Indication For Use (IFU) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Providing Instructions for Use (IFU) vs. 'Help' pages 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B Brazil requirements to have translations of IFU to Portuguese certified Other Medical Device Regulations World-Wide 16
C IFU Language Requirements for FDA Clinical Study conducted in EU EU Medical Device Regulations 3
P EU Electronic IFU (Instructions for Use) Requirements EU Medical Device Regulations 2
B Language Requirements - Labels/IFU (Professional Use Medical Devices) in Bangladesh Other Medical Device Regulations World-Wide 2
S IFU for combined OTC Medical Device in light of IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Electronic IFU's on Class III and IV Medical Devices World Wide Other Medical Device Regulations World-Wide 1

Similar threads

Top Bottom